Actively Recruiting
Saccharomyces Boulardii CNCM I-745 in Irritable Bowel Syndrome
Led by Biocodex · Updated on 2025-11-18
406
Participants Needed
10
Research Sites
50 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a double-blind, randomized (group assignment by chance), placebo-controlled, multicenter trial which will be conducted over a 13.5-months period The main objective of the research is to demonstrate the efficacy of Saccharomyces boulardii CNCM I-745 on global IBS symptoms, measured by the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS), in comparison to placebo after 8 weeks. Secondary efficacy objectives are to evaluate the impact of Saccharomyces boulardii CNCM I-745 on quality of life of IBS patients and on global and individual IBS symptoms, using the IBS-SSS, in comparison to placebo at regular intervals over a 3-month treatment period. This research also aims to evaluate the proportion of patients who improved ≥ 50 points on IBS-SSS and the proportion of responders according to the European Medicines Agency (EMA) definition (based on the patient's global assessment of efficacy and on abdominal pain score), after 8 weeks of treatment. Secondary safety objective is to evaluate the safety profile and tolerability of Saccharomyces boulardii CNCM I-745 capsules 500 mg/day in IBS patients in comparison to placebo
CONDITIONS
Official Title
Saccharomyces Boulardii CNCM I-745 in Irritable Bowel Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 65 years
- Diagnosis of IBS of any subtype except constipation-predominant (IBS-C) according to Rome IV criteria
- IBS Symptom Severity Scale (IBS-SSS) total score of 175 or higher at inclusion
- Able and willing to maintain usual nutrition habits during study participation
- Able to understand and willing to comply with study requirements and provide written informed consent
- Women of childbearing potential willing to use acceptable birth control methods throughout the study
You will not qualify if you...
- Diagnosis of constipation-predominant IBS (IBS-C) according to Rome IV criteria
- More than 5 bowel movements per day on average during screening period
- Severe illnesses or gastrointestinal diseases other than IBS, including ulcers, coeliac disease, inflammatory bowel disease, bowel cancer, infectious gastroenteritis, or need for enteral or parenteral nutrition
- History of abdominal surgery except appendectomy, cholecystectomy, hemorrhoid surgery, or cesarean section more than 6 months prior
- Familial colorectal cancer syndromes such as Lynch syndrome or Familial Adenomatous Polyposis
- Fecal transplant within 6 months before screening
- Use of prebiotics, probiotics, or synbiotics within 2 weeks before screening (except investigational product)
- Systemic antibiotic or antifungal treatment within 2 weeks prior to randomization
- Use of laxatives, antibloating agents, antidiarrheal medication, or antispasmodics within 2 weeks prior to screening (except rescue loperamide)
- Regular use of non-steroidal anti-inflammatory drugs (NSAIDs) above low-dose aspirin within 2 weeks prior and during study
- Use of opioids or narcotic analgesics including tramadol and codeine within 6 weeks prior to screening
- Treatment with two or more antidepressants, anxiolytics, or antipsychotics within 3 months prior or during trial
- Use of anticholinergic drugs for overactive bladder within 1 week prior to screening
- Allergy to yeast, especially Saccharomyces boulardii, or hypersensitivity to components
- Having a central venous catheter, being critically ill, or immunocompromised
- Rare hereditary problems with sugar intolerances or enzyme deficiencies
- Excessive alcohol use (more than 7 units per week) or drug abuse
- Other medical conditions or treatments that could interfere with study compliance or data
- Significant biological or clinical abnormalities incompatible with study participation
- Pregnant, breastfeeding, or at risk of pregnancy without contraception
- Under guardianship, curatorship, legal protection, or deprived of liberty
- Participation in another interventional clinical trial affecting results
- Current health status does not allow giving informed consent
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Hospital de Braga
Braga, Portugal
Actively Recruiting
2
Hospital da Luz
Lisbon, Portugal
Not Yet Recruiting
3
Hospital Universitario Vall d'Hebron
Barcelona, Spain, 08035
Not Yet Recruiting
4
Hospital Universitario de León
León, Spain, 24008
Actively Recruiting
5
Hospital Universitario Gregorio Marañon & Centro de Salud Pavones
Madrid, Spain, 28007
Actively Recruiting
6
Hospital Clínico San Carlos
Madrid, Spain, 28040
Not Yet Recruiting
7
Hospital Universitario La Paz & Hospital Carlos III
Madrid, Spain, 28046
Not Yet Recruiting
8
Hospital Universitario Costa del Sol
Marbella, Spain, 29603
Not Yet Recruiting
9
Hospital Universitario Regional de Málaga
Málaga, Spain, 29010
Not Yet Recruiting
10
Hospital Universitario Central de Asturias & Centro de Salud la Lila
Oviedo, Spain, 33011
Not Yet Recruiting
Research Team
E
Elise Miclot
CONTACT
H
Hugo-Miguel Dachez De Oliveira
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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